- Prequalified assays and Product Quality Attributes (PQA) assessment based on ICH guidance
- Viral clearance validation
Abzena has analytical capabilities to support all stages of product and process development. Validated analytical methods are available to support release of early phase clinical material.
Abzena’s standard platform assays and methods used for in-process testing and release of drug substance are qualified. The qualification examines a number of parameters based on applicable ICH guidance to show assay specificity, linearity and variability. Assays available at Abzena include:
- pH – potentiometric
- Identification – Isoelectric focusing, SDS-PAGE, Western blotting
- Purity – SDS-PAGE, SEC-HPLC, RP-HPLC
- HC Protein – ELISA
- HC DNA – QPCR
- Protein A – ELISA
- Protein Content – A280/BCA Assay
- Endotoxin – Kinetic Turbidimetic
- Bioburden – Culture
Viral Clearance Validation
Abzena can perform studies to provide a viral safety risk assessment.
Working with Abzena
Abzena’s mammalian manufacturing services are tailored for each project to ensure that the objectives are met or exceeded. Experienced project teams are assigned to each study focusing on progressing projects through to results in the minimum amount of time. Our clients widely regard us as professional and attentive partners who deliver quality results.
To get more information, a quote or to schedule a teleconference please contact us.